(27 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a guiding catheter, with no mention of AI or ML.
No.
The device description states it is used to provide a pathway for therapeutic and diagnostic devices, not to provide therapy itself.
No
Explanation: The device description states that the central lumen of the catheter is used for the passage and placement of diagnostic devices, but it does not perform diagnostic functions itself. It is explicitly designed to introduce other devices.
No
The device description clearly outlines a physical, flexible plastic tube with various components and features, indicating it is a hardware device. The performance studies also focus on physical and material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide a pathway for introducing therapeutic and diagnostic devices into the vascular system. It is a tool for accessing the body, not for performing tests on samples taken from the body.
- Device Description: The description details a physical catheter used for accessing blood vessels and delivering other devices. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD. The performance studies focus on the physical properties and safety of the catheter itself, not on the accuracy or reliability of diagnostic results obtained using the catheter.
In summary, the Convey Guiding Catheter is an interventional device used to facilitate procedures within the vascular system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and / or therapeutic (interventional) devices within the vascular system. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multipurpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "inline" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical design verification (bench) tests were conducted. The following in-vitro performance tests (following simulated use, if applicable, were completed of the 7F & 8F Convey Guiding Catheter: Visual Inspection, Shape Conformance & Shape Retention, Outer Diameter, Inner Diameter, Usable Catheter Length, Side Hole diameter & positioning, C-Kink (Bending Kink Diameter), Euler Kink (Axial Kink Displacement), Radial Stiffness (Collapse), Three Point Bending Test (Bending Stiffness Body), Pull Force Test (after simulated use), Coating location & length, Coating Integrity - Outer Friction & Wear functional test, Coating Integrity (after simulated use), Torque Strength (after simulated use), Body Strength / Burst Pressure test, Particulate testing, Radiopacity / Visibility testing. The results provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Bacterial Endotoxin-Mediated Pyrogenicity Testing, Bioburden testing, and Ethylene Oxide Residual Testing were conducted for sterility.
The Biocompatibility for the 7F & 8F Convey Guiding Catheter was leveraged from the biocompatibility tests completed on the 5F & 6F Convey™ Guiding Catheter. The following tests were conducted: ISO 10993-4: Haemocompatibility: Hemolysis, In vitro Haemocompatibility, Coagulation Tests Prothrombin Time Assay-PT, Coagulation Unactivated Partial Thromboplastin Time Assay-UP. ISO 10993-5: Cytotoxicity - MEM-elution (USP). ISO 10993-7: Ethylene Oxide Sterilization Residuals. ISO 10993-10: Sensitization (USP). ISO 10993-10: Irritation / Intracutaneous Reactivity (USP ). ISO 10993-11: Acute Systemic Toxicity (USP ). ISO 10993-11: Material Mediated Pyrogenicity (USP ). USP : Packaging Plastic Containers Leachables.
A Clinical Evaluation Study was not regarded for these devices as the modifications do not have an impact on the indications for use and on the safety and performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
510(k) Summary
per 21 CFR §807.92
| Submitter's
Name
Address | PendraCare International B.V.
Van der Waalspark 22
9351 VC Leek
The Netherlands | AUG 1 2 2013 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | FDA Establishment Registration Number 3005635992
Owner / Operator Number: 10041705 | |
| Contact Name &
Information | Bert Roossien, MSc, PhD.
Manager Quality Assurance & Regulatory Affairs
PendraCare International B.V.
Van der Waalspark 22
9351 VC Leek
The Netherlands | |
| | Phone: +31 594 554 077 (direct)
Phone: +31 594 510 755 (general)
Fax: +31 594 510 769
e-mail: broossien@pendracare.com | |
| Date prepared | 11 July, 2013 | |
| Proprietary Name | Convey™ Guiding Catheter | |
| Common Name | Percutaneous Catheter | |
| Classification | Class II, 21 CFR 870.1250 | |
| Review Panel | Cardiovascular | |
| Product Code | DQY | |
| Subject Devices | Convey™ 7F Guiding Catheter
Convey™ 8F Guiding Catheter | |
| Predicate Devices | Convey™ 5F Guiding Catheter (K120585; August 8, 2012)
Convey™ 6F Guiding Catheter (K120585; August 8, 2012) | |
1
The guiding catheter is a flexible plastic tube featuring a luer hub, a strain Device relief, a body, an intermediate tip, and a soft tip. The body and the Description intermediate tip exist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and / or therapeutic (interventional) devices within the vascular system. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multipurpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "inline" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded. The Convey Guiding Catheter is designed to provide a pathway through Intended Use of which therapeutic and diagnostic devices are introduced. The Convey Device Guiding Catheter is intended to be used in the coronary or peripheral vascular system. The Convey Guiding Catheter is designed to provide a pathway through Indications for which therapeutic and diagnostic devices are introduced. The Convey Use Guiding Catheter is intended to be used in the coronary or peripheral vascular system. The Convey™ 7F Guiding Catheter and Convey™ 8F Guiding Catheter Substantial incorporate substantially equivalent device materials and design, Equivalence packaging materials and design, intended use, fundamental technology (operating principle & mechanism of action), labeling and manufacturing processes and sterilization process as those featured in the legally marketed predicate devices, the Convey™ 5F Guiding Catheter and Convey™ 6F Guiding Catheter (K120585, clearance: August 8, 2012).
2
| Summary of
Non-clinical
Testing | To support a determination of substantial equivalence, data was collected
from non-clinical design verification (bench) tests. The results provide
reasonable assurance that the proposed device has been designed and
tested to assure conformance to the requirements for its intended use. | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | The following in-vitro performance tests (following simulated use, if
applicable, were completed of the 7F & 8F Convey Guiding Catheter:
Visual Inspection,
●
Shape Conformance & Shape Retention,
●
Outer Diameter,
�
Inner Diameter,
Usable Catheter Length,
●
Side Hole diameter & positioning,
�
C-Kink (Bending Kink Diameter),
�
Euler Kink (Axial Kink Displacement),
●
Radial Stiffness (Collapse),
●
Three Point Bending Test (Bending Stiffness Body),
●
Pull Force Test (after simulated use),
Coating location & length
●
Coating Integrity - Outer Friction & Wear functional test,
Coating Integrity (after simulated use),
Torque Strength (after simulated use),
�
Body Strength / Burst Pressure test,
Particulate testing,
Radiopacity / Visibility testing.
� | |
| Summary of
Sterility Testing | Bacterial Endotoxin-Mediated Pyrogenicity Testing,
Bioburden testing,
●
Ethylene Oxide Residual Testing.
● | |
| Summary of
Biocompatibility
Testing | The Biocompatibility for the 7F & 8F Convey Guiding Catheter was
leveraged from the biocompatibility tests completed on the 5F & 6F
Convey™ Guiding Catheter. The following tests were conducted:
ISO 10993-4: Haemocompatibility:
�
o Hemolysis
o In vitro Haemocompatibility
Coagulation Tests Prothrombin Time Assay-PT
o Coagulation Unactivated Partial Thromboplastin Time Assay-UP
ISO 10993-5: Cytotoxicity - MEM-elution (USP)
ISO 10993-7: Ethylene Oxide Sterilization Residuals
●
ISO 10993-10: Sensitization (USP)
●
ISO 10993-10: Irritation / Intracutaneous Reactivity (USP )
●
ISO 10993-11: Acute Systemic Toxicity (USP )
●
ISO 10993-11: Material Mediated Pyrogenicity (USP )
◆
USP : Packaging Plastic Containers Leachables | |
3
.
| Summary of
Clinical Testing | Since the modifications do not have an impact on the indications for use
and on the safety and performance of the device, a Clinical Evaluation
Study was not regarded for these devices. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | In summary, the modifications in the subject devices Convey™ 7F
Guiding Catheter and Convey™ 8F Guiding Catheter do not affect the
intended use and does not alter the fundamental scientific technology of
the device. The subject devices Convey™ 7F Guiding Catheter and
Convey™ 8F Guiding Catheter are substantial equivalent to the predicate
devices Convey™ 5F Guiding Catheter (K120585, dated 8 August 2012)
and Convey™ 6F Guiding Catheter (K120585, dated 8 August 2012) with
respect to the intended use, fundamental technology, i.e., operating
principle, device materials, design, packaging materials & configuration,
labeling, manufacturing & sterilization processes and sterility assurance
level. |
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2013
Pendracare International, B.V. % Mr. Tom Nolan Managing Director Corvitex Corporation 7205 Laketree Dr Raleigh, NC 27615
K132197 Re:
Trade/Device Name: Convey™ 7F Guiding Catheter, Convey™ 8F Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 11, 2013 Received: July 16, 2013
Dear Mr. Nolan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1f your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2- Mr. Tom Nolan
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillerman
for
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known):
Convey™ 7F Guiding Catheter, Device Name:
Convey™ 8F Guiding Catheter
Indications for Use:
The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillemann
(Division Sign-Off) Division of Cardiovascular Devices K132197 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
.